PLE xUR P - SeattleClouds.comseattleclouds.com/.../cheekeebowman/test/25029PLexurPbrochure1.pdfMineralized Cortical Bone Fibers Resorbable Polymer Electron Microscopy Scan of Cell

LITP

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Medtronic Spinal and Biologics Business Worldwide Headquarters

2600 Sofamor Danek DriveMemphis, TN 38132

1800 Pyramid PlaceMemphis, TN 38132

(901) 396-3133(800) 876-3133Customer Service: (800) 933-2635

For more information visit www.myspinetools.com

www.medtronic.com

Please see the package insert for the complete list of indications, warnings, precautions, and other medical information.

A Cut Above

» Compressive Resistance

» 3D-Biocomposite Technology

» Ability to be Customized

» Ability to Wick Blood or Marrow

PLExUR P®Preformed Biocomposite

Product Information

Product Ordering Information

PLEXUR P® Preformed Biocomposite

Part NumberDescription

6000-005Granules, 5cc




6000-107Cylinder, 7mm × 25mm



6000-210Wedge, 40mm × 15mm × 10°

6000-215Wedge, 40mm × 15mm × 15°6000-310Block, 10mm × 10mm × 20mm6000-320Block, 20mm × 20mm × 20mm

6000-425Sheet, 50mm × 25mm × 4mm

6000-525Sheet, 100mm × 25mm × 4mm

Mineralized Cortical Bone Fibers Resorbable Polymer

Electron Microscopy Scan of Cell Attachment—14 Days*

Rabbit Distal Femoral Defect—12 Weeks*†

Interconnected Porosity Wicks Blood and BMA Cellular-Friendly Environment Scaffold Supports

Bone Formation

*Based on internal testing.†Histology: Goldner’s trichrome stain, 2x original magnification.

PLExUR P® Preformed Biocomposite | PRODUCT InfORmaTIOnPLExUR P® Preformed Biocomposite | PRODUCT InfORmaTIOn

3-Dimensional Scaffold Technology

PLEXUR P® Preformed Biocomposite | PRODUCT infORmaTiOn

Designed for Intraoperative Handling and Placement

W e d g e s | B l o c k s | G r a n u l e s | S h e e t s | C y l i n d e r s

Can be Contoured to Fit the Defect Can be Drilled to Accommodate Provisional Hardware

Resists Impaction Helps Restore and Maintain Articular Height Through Healing


Surgical Challenges Require Versatile Intraoperative Solutions PLEXUR P® Preformed Biocomposite is not to be used for structural support.

Bone Void Filler Cases Preoperative Operative

Triple Arthrodesis» 64-year-old male with chronic posterior tibialis dysfunction

resulting in a painful, unstable hindfoot.

» Patient underwent triple arthrodesis, with the hindfoot reduced to a mild valgus position and fixed with screws.

» 9mm PLEXUR P® Cylinders were impacted into predrilled tunnels in the subtalar and talonavicular joints.

Calcaneus Fracture» 66-year-old male sustained left calcaneal fracture after a fall.

» Patient underwent open reduction and internal fixation through a standard extensile lateral approach.

» After anatomic reduction, the resultant defect was filled with a 20mm × 20mm × 20mm PLEXUR P® Block, cut in half and shaped to fit under Gissane’s angle and into the tuberosity.

Evans Osteotomy» 50-year-old male, rating his pain an 8 out of 10 and unable

to perform single leg heel raise.

» Surgery involved an opening wedge with a 10° PLEXUR P® Wedge inserted into the osteotomy and fixed with a plate and screws.


Wedges

Blocks

Cylinders

As described by: John Early, MD; Foot and Ankle Specialist; Texas Orthopedics Associates, LLP; Dallas, Texas

As described by: Alan Garrett, DPM, FACFAS; University of North Texas; Fort Worth, Texas

» Patient was initially nonweight bearing with crutches progressing to weight bearing.

» Patient was able to return to work in a reduced workload at 3 months and reported no problems.

» Wedges fit and fill the osteotomy, providing uninterrupted graft appositive for bone healing. Wedges resist impaction.

» Complete resolution of swelling and full activity to the patient’s satisfaction were obtained at 4 months.

» Blocks help restore and maintain articular height through healing.

» Patient was placed in a cast with no weight bearing for 6 weeks and progressed to weight bearing.

» Patient was weight bearing without complaints at 3 months from surgery.

» Cylinders assist at the fusion site.

PLEXUR P® Preformed Biocomposite Postoperative X-raysMultiple Handling Options

As described by: John Early, MD; Foot and Ankle Specialist; Texas Orthopedics Associates, LLP; Dallas, Texas


PLEXUR P® Preformed Biocomposite Does Not Fracture When Compressed*

PLEXUR P® Preformed Biocomposite is a unique combination of mineralized cortical fibers suspended in a porous, resorbable scaffold that contains the necessary and natural components for optimal bone healing.

PLEXUR P® Preformed Biocomposite is available in multiple shapes and sizes that can be used for bony voids of the skeletal system: spine, pelvis, extremities. With a spongy consistency much like that of cancellous bone, PLEXUR P® Preformed Biocomposite packs while maintaining shape and porosity and can be intraoperatively manipulated to meet complex surgical challenges.

PLEXUR P® Preformed Biocomposite should not be used for structural support.

Plexur P® Preformed Biocompositeb-TCP FoamCancellous Chips

b-TCP = beta-tricalcium phosphate.*Based on internal testing.

LOAD

LOAD

Mineralized Cortical Bone Fibers Resorbable Polymer

Electron Microscopy Scan of Cell Attachment—14 Days*

Rabbit Distal Femoral Defect—12 Weeks*†

Interconnected Porosity Wicks Blood and BMA Cellular-Friendly Environment Scaffold Supports

Bone Formation

*Based on internal testing.†Histology: Goldner’s trichrome stain, 2x original magnification.

PLExUR P® Preformed Biocomposite | PRODUCT InfORmaTIOnPLExUR P® Preformed Biocomposite | PRODUCT InfORmaTIOn

3-Dimensional Scaffold Technology

LITPLPBR11 ©2010 M

edtronic Sofamor D

anek USA, Inc. All Rights Reserved. U

C201201031IE PMD

005468-1.0/0711






www.medtronic.com


A Cut Above





PLExUR P®

Preformed Biocomposite

Product Information



Part Number Description

6000-005 Granules, 5cc




6000-107 Cylinder, 7mm × 25mm



6000-210 Wedge, 40mm × 15mm × 10°

6000-215 Wedge, 40mm × 15mm × 15°6000-310 Block, 10mm × 10mm × 20mm6000-320 Block, 20mm × 20mm × 20mm

6000-425 Sheet, 50mm × 25mm × 4mm

6000-525 Sheet, 100mm × 25mm × 4mm

LITP

LPBR

11 ©

2010

Med

tron

ic S

ofam

or D

anek

USA

, Inc

. All

Righ

ts R

eser

ved.

UC2

0120

1031

IE P

MD

0054

68-1

.0/0

711






www.medtronic.com


A Cut Above





PLExUR P®Preformed Biocomposite

Product Information



Part NumberDescription








6000-210Wedge, 40mm × 15mm × 10°

6000-215Wedge, 40mm × 15mm × 15°6000-310Block, 10mm × 10mm × 20mm6000-320Block, 20mm × 20mm × 20mm

6000-425Sheet, 50mm × 25mm × 4mm

6000-525Sheet, 100mm × 25mm × 4mm

Documents

PLE xUR P - SeattleClouds.comseattleclouds.com/.../cheekeebowman/test/25029PLexurPbrochure1.pdfMineralized Cortical Bone Fibers Resorbable Polymer Electron Microscopy Scan of Cell